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Trial record 27 of 188 for:    GLYCOPYRROLATE

Effect of Sugammadex vs. Neostigmine/Glycopyrrolate on Pediatric Emergence Delirium in Sevoflurane-rocuronium Anesthesia

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ClinicalTrials.gov Identifier: NCT03229486
Recruitment Status : Recruiting
First Posted : July 25, 2017
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Tae-Kyun Kim, Pusan National University Yangsan Hospital

Tracking Information
First Submitted Date  ICMJE June 29, 2017
First Posted Date  ICMJE July 25, 2017
Last Update Posted Date September 5, 2018
Actual Study Start Date  ICMJE October 17, 2017
Estimated Primary Completion Date April 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2017)
PAED Score [ Time Frame: within 30 minutes after arrival at post-anesthesia care unit (PACU) ]
maximum Pediatric Anesthesia Emergence Delirium (PAED) score after arrival in the PACU
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03229486 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2017)
  • Time recovery of TOF ratio to 0.7, 0.8, and 0.9 [ Time Frame: Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.7, 0.8, and 0.9, assessed up to 60 minutes ]
    Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.7, 0.8, and 0.9
  • Time to regular breathing [ Time Frame: time from administration of reversal agent to time of deep, regular breathing, assessed up to 60 minutes ]
    time from administration of reversal agent to time of deep, regular breathing
  • Time to awakening [ Time Frame: time from administration of reversal agent to time of eye opening or child showing purposeful movements, assessed up to 60 minutes ]
    time from administration of reversal agent to time of eye opening or child showing purposeful movement
  • Time to extubation [ Time Frame: time from administration of reversal agent to time of tracheal extubation, assessed up to 60 minutes ]
    time from administration of reversal agent to time of tracheal extubation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Sugammadex vs. Neostigmine/Glycopyrrolate on Pediatric Emergence Delirium in Sevoflurane-rocuronium Anesthesia
Official Title  ICMJE A Prospective, Double-blind, Randomized Study to Investigate the Effect of Sugammadex vs. Neostigmine/Glycopyrrolate on Emergence Delirium During Sevoflurane-rocuronium Anesthesia in Pediatric Patients
Brief Summary

The aim of this study is to investigate the effect of sugammadex vs. a conventional acetylcholinesterase inhibitor, neostigmine on emergence delirium (ED) during sevoflurane-rocuronium anesthesia in pediatric patients Additionally, the efficacy features of sugammadex compared to neostigmine will be examined by measuring the time from start of administration of reversal agents to recovery of train-of-four (TOF) ratio to 0.7, 0.8, and 0.9.

Although the etiology of ED remains unclear, a sense of suffocation or breathing difficulty during emergence from anesthesia has been suggested as a possible cause. Thus, reversal of neuromuscular blockade with sugammadex in pediatric patients maintained with sevoflurane-rocuronium anesthesia may decrease ED due to its faster reversal of neuromuscular blockade and decreased possibility of residual blockade.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Emergence Delirium
Intervention  ICMJE
  • Drug: Sugammadex Injection [Bridion]
    Return to T2 point (two contractions) on TOF device is replied by iv 2 mg/kg sugammadex administration, contained in a blinded syringe.
  • Drug: Neostigmine+Glycopyrronium
    Return to T2 point (two contractions) on TOF device is replied by iv 0.06 mg/kg neostigmine and 0.005 mg/kg glycopyrrolate administration, contained in a blinded syringe.
Study Arms  ICMJE
  • Experimental: Sugammadex Injection [Bridion]
    reversal of neuromuscular blockade with sugammadex
    Intervention: Drug: Sugammadex Injection [Bridion]
  • Active Comparator: Neostigmine+Glycopyrronium
    reversal of neuromuscular blockade with neostigmine & glycopyrrolate
    Intervention: Drug: Neostigmine+Glycopyrronium
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 23, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2019
Estimated Primary Completion Date April 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • American Society of Anesthesiologist (ASA) physical status I or II, preschool children scheduled for an elective tonsillectomy with or without adenoidectomy will be included in the study.

Exclusion Criteria:

  • Patients will be excluded in cases of emergency surgery, developmental, psychological, cognitive or communication disorders, known or suspected neuromuscular disorders that may impair neuromuscular blockade, significant renal or hepatic dysfunction, coagulation disorders, family history of malignant hyperthermia, allergy to any of the drugs included in the study protocol, or usage of medication known to interact with rocuronium or sugammadex.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 7 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Juyeon Park, MD 82553602129 monojp@pusan.ac.kr
Contact: Tae-Kyun Kim, MD, PhD 82553602129 anesktk@pusan.ac.kr
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03229486
Other Study ID Numbers  ICMJE PusanNUYH
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Tae-Kyun Kim, Pusan National University Yangsan Hospital
Study Sponsor  ICMJE Pusan National University Yangsan Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tae-Kyun Kim, MD, PhD Pusan National University Yangsan Hospital
PRS Account Pusan National University Yangsan Hospital
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP